Release date- 29072019 - KENILWORTH - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending ZERBAXA 3g dose (ceftolozane and
tazobactam) for an additional indication for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), in adults.
Piperacillin, given in combination with efficiency-booster
tazobactam, is a broad-spectrum antibiotic used to combat serious infections such as sepsis or pn eumonia.
The United States Food and Drug Administration (FDA) has approved a new indication for the earlier approved Zerbaxa (ceftolozane and
tazobactam) intended for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older, it was reported yesterday.
Biopharmaceutical company Merck (NYSE:MRK) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for the use of ZERBAXA (ceftolozane and
tazobactam) for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) that are proven or strongly suspected to be caused by susceptible bacteria.
Piperacillin-tazobactam (PTZ) is a combination of piperacillin and the blactamase inhibitor
tazobactam. Piperacillin-tazobactam has a broad-spectrum antibacterial activity that covers aerobic gram-positive, gram-negative, and anaerobic bacteria but does not cover MRSA [2, 3].
In a pilot study, piperacillin (87 mg/kg) in combination with
tazobactam (11 mg/kg) was administered intramuscularly (IM) to 2 birds, and blood samples were obtained at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours after administration.
cefixime, ceftazidime, co-trimoxazole, ciprofloxacin, gentamicin, amikacin, cefoperazone + sulbactam, piperacillin +
tazobactam, meropenem, polymyxin - B, and aztreonam were used.
They tested 12 of the most common types of antibiotics, finding that two combinations in particular - piperacillin and
tazobactam, and imipenem and cilastatin - led to a higher risk of a life-threatening inflammatory condition called graft-versus-host disease (GVHD).
Although bone marrow suppression with leucopenia is mentioned as an important side effect of piperacillin/
tazobactam, isolated thrombocytopenia without affection of red cells and leucocytosis has been reported only in few cases.